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SECTION 11 71 01
MEDICAL WASHING AND STERILIZING EQUIPMENT
SPEC WRITER NOTES:
1. Delete between // ____ // if not
applicable to project.
2. Delete other items or paragraphs in
section that are not applicable and
renumber the paragraphs.
PART 1 - GENERAL
1.1 DESCRIPTIONS
This section specifies Medical Reprocessing and Sterilization Equipment
including washer disinfectors, cart washers, ultrasonic cleaners,
automated endoscope re-processors, steam sterilizers, ethylene oxide
(EtO) sterilizer/aerator combination units, ethylene oxide (EtO)
abators, plasma sterilizers, ethylene oxide (EtO) monitoring stations,
liquid chemical sterilizers, drying cabinets, detergent dispensing
units, water treatment systems, steam guns, and endoscope preprocessing sinks.
1.2 DEFINITIONS
A. Ultrasonic Cleaner: A mechanical system that uses sound waves, water
and detergent to loosen soil from instruments. Both countertop and
floor units are available.
B. Washer/Disinfector: An automated washing unit that uses hightemperature water and detergent to clean and high-level disinfect
instruments and trays.
1. Cube Model – Single chamber washer/disinfector.
2. Tunnel Model – Multiple chamber washer/disinfector.
C. Cart Washer: An automated washing unit that uses high-temperature water
and detergent to clean and high-level disinfect carts and equipment.
D. Endoscope Drying Cabinet: Freestanding cabinet used to dry endoscopes
with forced, filtered air within the cabinet, as well as through the
channels of the scopes.
E. Equipment Drying Cabinet: Freestanding cabinet used to dry equipment
with forced, filtered air and variable temperature settings. There are
single door and pass-thru units available.
F. Automated Endoscopic Re-Processor (AER): Automated washing unit that
uses water and EPA-approved high level disinfectants to clean and high
level disinfect immersible, flexible endoscopes.
G. Steam Sterilizer: A machine used to sterilize instruments and equipment
by subjecting them to high-pressure steam up to 275°F. Sterilizers are
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available in both cart-loading and floor-loading models. They can be
either freestanding or recessed, with single or double doors (passthru). Steam sterilizers are also known as autoclaves.
H. Ethylene-Oxide (EtO) Sterilizer/Aerator Combination: A machine that
combines the sterilization and aeration process into one unit. Ethylene
Oxide gas is used to sterilize heat-sensitive instruments and equipment
by subjecting them to a temperature of up to 130°F, and an aeration
cycle immediately follows the sterilization cycle. ETO sterilizers can
be freestanding or recessed, with single doors.
A dedicated exhaust
system is required for Ethylene Oxide.
I. Ethylene Oxide (EtO) Disposal System (Abator): A machine used as a
pollution-control device, that converts ethylene oxide gas exhausted
from sterilizer/aerator units to CO2 and water vapor through a heated
catalytic process.
J. Ethylene Oxide (EtO) Monitoring Station: A continuous monitoring device
(Single point or multi-point system) used to detect Ethylene Oxide
leakage into the room.
K. Gas Plasma Sterilizer: A machine that uses hydrogen peroxide gas plasma
to sterilize heat-sensitive instruments and equipment. These
sterilizers are available as either floor, cart, or counter-mounted.
L. Liquid Chemical Sterilizer: A machine that uses a low-temperature
liquid chemical sterilant to process heat-sensitive rigid and
flexible endoscopes.
M. Water Treatment System: A mechanical system for use with steam
sterilizers, washer/disinfectors and cart washers, that decreases the
contaminates in the municipal water to reduce boiler scaling and
instrument spotting.
N. Detergent Dispensing System: A mechanical system that dispenses
measured doses of detergent or other chemicals directly to washer
disinfectors and cart washers.
O. Steam Gun: Refer to Section 23 22 13, STEAM AND CONDENSATE HEATING
PIPING.
P. Endoscope Pre-Processing Sink: Refer to Section 22 40 00, PLUMBING
FIXTURES.
1.3 RELATED WORK
A. Section 22 11 00, FACILITY WATER DISTRIBUTION and // Section 22 13 00,
FACILITY SANITARY SEWERAGE // Section 22 66 00, CHEMICAL-WASTE SYSTEMS
FOR LABORATORY AND HEALTHCARE FACILITIES //:Plumbing Connections.
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B. Section 22 15 00, GENERAL SERVICE COMPRESSED-AIR SYSTEMS: Connections
to Compressed Air System.
//C. Section 22 40 00, PLUMBING FIXTURES.//
D. Section 23 05 11, COMMON WORK RESULTS FOR HVAC.
E. Section 23 22 13, STEAM AND CONDENSATE HEATING PIPING: Steam
Connections//, Steam Gun//.
//F. Section 23 09 23, DIRECT-DIGITAL CONTROL SYSTEM FOR HVAC: Remote
monitoring of the Steam Sterilizers and EtO Monitoring system.//
G. Section 26 05 11, REQUIREMENTS FOR ELECTRICAL INSTALLATIONS: Electrical
Connections.
1.4 PERFORMANCE REQUIREMENTS
SPEC WRITER NOTE: Check with user to
verify service characteristics required
for equipment.
A. Equipment shall have built-in monitoring for timed cycles, and control
devices for proper temperature and pressure. Equipment shall have a
printer, either integrated or remote, for recording cycle time,
temperature, and pressure.
B. Manufacturer safeguards must be provided with the equipment to protect
the operator from harm during normal operation of the equipment.
1.5 QUALITY CONTROL
A. Refer to Section 23 05 11, COMMON WORK RESULTS FOR HVAC: Quality
Assurance 1.3.D - Products Criteria.
B. Mechanical, electrical, and associated systems shall be safe, reliable,
efficient, durable, easily and safely operable, maintainable, and
accessible.
C. Standard Products: Material and equipment shall be the standard
products of the selected manufacturer, and they should be regularly
engaged in the manufacture of such products for at least 3 years.
The
design, model and size of each item shall have been in satisfactory and
efficient operation on at least three installations for approximately
three years.
However, digital electronics devices, software and
systems such as controls, instruments, computer work stations, shall be
the current generation of technology and basic design that has a proven
satisfactory service record of at least three years.
D. All items furnished shall be free from defects that would adversely
affect the performance, maintainability and appearance of individual
components and overall assembly.
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E. Multiple Units: When two or more units of materials or equipment of the
same type or class are required, these units shall be products of one
manufacturer.
F. Nameplates: Nameplate bearing manufacturer’s name or identifiable
trademark shall be securely affixed in a conspicuous place on
equipment, or name or trademark cast integrally with equipment, stamped
or otherwise permanently marked on each item of equipment.
G. Installer Qualifications: Installer is authorized representative of
sterilizer manufacturer and employs factory-trained personnel to
install sterilizers. Installer is licensed as may be necessary by
regulatory organizations.
H. Steam Sterilizers: Comply with the most current version of ANSI/AAMI
ST8.
I. Ethylene-Oxide Sterilizers: Comply with the most current version of
ANSI/AAMI ST24.
1.6 SUBMITTALS
A. Submit in accordance with specification Section 01 33 23, SHOP
DRAWINGS, PRODUCT DATA, AND SAMPLES.
B. Manufacturer’s Literature and Data: Include the following:
1. Illustrations and descriptions of medical reprocessing equipment.
2. Optional auxiliary equipment and controls.
3. Catalog or model numbers for each component.
4. Utility requirements.
C. Shop Drawings: Show details of fabrication, installation, adjoining
construction, coordination with mechanical and electrical work,
anchorage, and other work required for complete installation.
D. Field Test Reports:
Provide certification reports from accredited
service technicians or installers.
E. Operating Instructions: Comply with requirements in specification
Section 01 00 00, GENERAL REQUIREMENTS.
1.7 APPLICABLE PUBLICATIONS
A. The publications listed below form a part of this specification to the
extent referenced. The publications are referenced in the text by the
basic designation only.
B. American National Standards Institute/Association for the Advancement
of Medical Instrumentation (ANSI/AAMI):
ST8-2008................Hospital Steam Sterilizer, 3rd edition
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ST24-1999 (R2009).......Automatic, General-Purpose Ethylene Oxide
Sterilizers and Ethylene Oxide Sterilant
Sources Intended for Use in Health Care
Facilities
C. National Association of Architectural Metal Manufacturers (NAAMM):
AMP 500-06..............Metal Finishes Manual
1.8 WARRANTY
Comply with FAR clause 52.246-21 in all areas except for warranty
period, which shall be two years for all equipment.
1.9 GUARANTEE PERIOD SERVICES
Engage factory-trained authorized manufacturers’ representatives to
perform maintenance service on equipment during guarantee period.
1. Maintenance Service:
a. Inspection of equipment at regularly scheduled intervals as
defined by the manufacturer.
b. Testing, cleaning, adjusting, repairing, and furnishing and
installing replacement components as required to maintain
equipment in reliable working condition.
2. Maintenance service does not include cleaning, adjusting, repairing,
furnishing and installing replacement components required because of
improper use.
PART 2 - PRODUCTS
SPEC WRITER NOTES:
1. Show utility service requirements for
sterilizers on drawings.
2. Verify that dedicated exhaust service,
venting directly to exterior, without
recirculating, is supplied for
sterilizers. Need for the dedicated
exhaust system should be verified with
the manufacturer and the VA Design
Manual.
2.1 ULTRASONIC CLEANER
SPEC WRITER NOTE: Chamber sizes vary.
Insert sizes based on project
requirements.
A. Floor Model:
1. Chamber:
a. Interior: Stainless steel.
b. Tank capacity: 11 gallons to 20 gallons.
2. Doors:
a. Quantity: Single.
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b. Operation: // Manual // Automatic //.
3. Loading: Manual.
4. Heat Source: // Electric //.
5. Temperature:
a. Solution tank: 100° - 120°F.
6. Electrical Requirements: // 120V // 208V // 240V //.
B. Countertop Model:
1. Chamber:
a. Interior: Stainless steel.
b. Tank capacity: 3 gallons to 6 gallons.
2. Doors:
a. Quantity: Single.
b. Operation: Manual.
3. Loading: Manual.
4. Heat Source: Electric.
5. Temperature:
a. Solution tank: ambient to 176°F.
6. Electrical Requirements: // 120V // 08V //.
2.2 WASHER/DISINFECTOR
SPEC WRITER NOTE: Chamber sizes vary.
Insert sizes based on project
requirements.
A. Tunnel(Multi-Chamber)Model:
1. Interior: Stainless steel.
2. Doors:
a. Quantity: Double (Pass-thru).
b. Operation: Automatic.
3. Loading: // Manual // Automatic //.
4. Controls: // Microprocessor // PC Based //.
5. Heat Source: // Steam // Electric //.
6. Electrical Requirements: // 208V // 480V //.
7. Standard Cycles: // Wash // Rinse // Dry //.
8. Optional Cycles: // Prewash // Ultrasonic // Thermal Disinfection
Rinse //.
9. Temperature:
a. Wash Cycle: // 140 – 180°F //.
b. Rinse Cycle: // 180 - 194°F //.
B. Cube Model:
1. Chamber Interior: Stainless steel.
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2. Doors:
a. Quantity: // Single // Double (Pass-thru) //.
b. Operation: // Manual // Automatic //.
3. Loading: // Manual // Automatic //.
4. Controls: // Microprocessor // PC Based //.
5. Heat Source: // Steam // Electric //.
6. Electrical Requirements: // 208V // 240V //.
7. Standard Cycles: // Wash // Rinse //.
8. Optional Cycles: // Purified Water Rinse // Dry //.
9. Temperature:
a. Wash Cycle: 140 - 180°F.
b. Rinse Cycle: 158 - 194°F.
2.3 CART WASHER
SPEC WRITER NOTE: Chamber sizes vary.
Insert sizes based on project
requirements.
A. Interior: Stainless steel.
1. Chamber Capacity: 134 – 241 cu. ft.
B. Doors:
1. Quantity: // Single (Pass-thru) // Double (Pass-thru) //.
2. Operation: Automatic.
C. Controls: // Microprocessor // PC Based //.
D. Heat Source: // Steam // Electric //.
E. Electrical Requirements: // 208V // 380V // 480V // 600V //.
F. Standard Cycles: // Wash // Rinse // Dry //.
G. Optional Cycles: Thermal Disinfection Rinse.
H. Installation Options: // Floor mount // Pit mount //.
I. Temperature:
1. Wash Cycle: 120 - 180°F.
2. Rinse Cycle: 180 - 194°F.
J. Loading: Manual.
2.4 ENDOSCOPE DRYING CABINET
A. Chamber:
1. Interior: // Painted steel // Stainless Steel //.
2. Capacity: Up to 10 Endoscopes.
B. Doors:
1. Quantity: // Single // Double //.
2. Operation: Manual.
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3. Configuration: // Side hinged // Front opening // Back opening (Pass
Through) //.
C. Loading: Manual.
D. Heat Source: Electric:
1. Cabinet Temperature: 149 – 158 degrees F.
2. Standard Drying Time: 0 - 120 minutes.
E. Cabinet Filtration: HEPA filtered air through chamber and internal
endoscope channels.
F. Air Flow Monitoring: Constant.
G. Electrical Requirements: 120V.
2.5 EQUIPMENT DRYING CABINET
A. Chamber:
1. Interior: Stainless steel.
2. Capacity: Up to 9 Shelves or cassettes.
B. Doors:
1. Quantity: // Single // Double (Pass Through) //.
2. Operation: Manual.
3. Configuration: // Side hinged // Front opening // Back opening (Pass
Through) //.
C. Loading: Manual.
D. Heat Source:
Electric.
1. Cabinet Temperature: 158 – 194 degrees F.
2. Standard Drying Time: 0 - 90 minutes.
E. Cabinet Filtration: HEPA filtered air.
F. Electrical Requirements: 120V.
2.6 AUTOMATIC ENDOSCOPE RE-PROCESSOR (AER)
SPEC WRITER NOTE: Chamber configurations
vary. Insert sizes based on project
requirements.
A. Configuration: Free Standing.
B. Chamber:
1. Chamber Quantity: // Single // Double // Triple //.
2. Chamber Processing Capacity: // 1 scope // 2 scopes //.
C. Standard Cycle:
1. Time: 22 – 42 minutes.
D. Printer: // Integrated // Remote Printer //.
E. Water Pressure: 30 – 70 PSI.
F. Electrical Requirements: // 110V // 120V // 208V // 220V // 230V //
460V //.
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2.7 STEAM STERILIZER
SPEC WRITER NOTE: Chamber sizes vary.
Insert sizes based on project
requirements.
A. Chamber:
1. Interior: Stainless steel.
2. Chamber Sizes: // Small (4.6 to 9.7 cu. ft.) // Medium (10.5 to 20.7
cu. ft.) // Large (39.6 to 72 cu. ft.) //.
3. Chamber Pressure: up to 45 PSIG.
4. Chamber Temperature: 230 - 275 degrees F.
B. Doors:
1. Quantity: // Single // Double (Pass-thru) //.
2. Operation: // Manual // Power //.
3. Configuration: // Vertical sliding // Hinged door // Front opening
// Back opening (Pass through) //.
C. Standard Cycles: // Gravity // Vacuum //.
D. Heat Source: // Steam // Electric //.
E. Loading: Manual.
F. Recorder: // Integrated Printer // Remote printer //.
G. Control Options: // Integrated controls // Remote controls //.//Provide
remote monitoring of the steam sterilizer via the DDC control system.
Coordinate interface with Section 23 09 23, DIRECT-DIGITAL CONTROL
SYSTEM FOR HVAC.//
H. Installation Options: // Floor mount // Pit mount //.
I. Electrical Requirements: // 110V // 208V // 480V //.
2.8 ETHYLENE-OXIDE STERILIZER/AERATOR COMBINATION
SPEC WRITER NOTE: Chamber sizes vary.
Insert sizes based on project
requirements.
A. Chamber:
1. Interior: Stainless steel.
2. Size: 4.8 cu. ft. to 7.9 cu.ft.
B. Cycle Time:
1. Exposure: 0 to 99 hours.
2. Aeration: 0 to 99 hours.
3. Chamber Pressure:
Minimum 80 psi.
4. Warm Sterilization Temperature: 55 degrees C (131 degrees F).
5. Cold Sterilization Temperature: 37 degrees C (98.6 degrees F).
6. Warm Aeration Temperature: 54 degrees C (130 degrees F).
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7. Cold Aeration Temperature: 38 degrees C (100 degrees F).
C. Doors:
1. Quantity: Single.
2. Operation: // Manual // Automatic //.
D. Recorder: // Integrated Printer // Remote Printer //.
E. Installation Options: // Freestanding // Recessed //.
F. Electrical Requirements: // 120V // 220V //.
G. Vent Outlet: Ethylene oxide vent pipe connection for vent pipe
connection to abator.
H. Sterilant Delivery System:
Single-Use Gas cartridge.
2.9 ETHYLENE-OXIDE ABATOR
SPEC WRITER NOTE: Obtain an abator when
an ethylene oxide sterilizer will be
used. Per VA Policy, provide one Abator
per Sterilizer. Coordinate electrical
requirements with available facility
power.
A. System Components:
1. Catalytic cell.
2. Heater.
3. Blower (Fan): // 115V // 230V //.
4. Prefilter.
5. Interconnection Kit: Links abator to ethylene-oxide sterilizer.
6. Construction: Stainless Steel.
7. Electrical Requirements: // 200V // 220V // 400V //.
B. Vent Accessories:
1. Inlet Vent: Ethylene oxide vent pipe connection for vent pipe
connection to sterilizer.
2. Outlet Vent: Exhaust discharge connection. Provide 3 way blender
exhaust discharge fitting with exhaust duct connection to mix high
temperature abator discharge with room air for low temperature
abator exhaust.
3. Auxiliary Vent: Ethylene oxide emergency vent pipe connection for
vent pipe connection to outdoors.
2.10 ETHYLENE-OXIDE (ETO) MONITOR:
SPEC WRITER NOTE: Obtain an EthyleneOxide monitoring device when an ethyleneoxide sterilizer will be used.
A. System Components:
1. Electro Chemical Sensors Range 0-100 PPM (EtO/organic vapor).
2. Pre-filter to allow for greater specificity.
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3. Supervisory panel where readings can be taken.
4. Alarm and strobe device (audible and visual alarm).
5. Second alarm for notification (Police, Fire Dept, etc.).
//6. Provide remote monitoring of the EtO monitoring system via the DDC
control system.
Coordinate interface with Section 23 09 23, DIRECT-
DIGITAL CONTROL SYSTEM FOR HVAC.//
2.11 GAS PLASMA STERILIZER (HYDROGEN PEROXIDE):
SPEC WRITER NOTE: Chamber sizes vary.
Insert sizes based on project
requirements.
A. Chamber:
1. Interior: Aluminum.
2. Capacity: 1.1 cu. ft. to 9.5 cu. ft.
3. Standard Cycle:
a. Table top: 28 to 38 minutes.
b. Floor Unit: 47 to 75 minutes.
4. Cycle Temperature: Up to 131 °F.
5. Sterilant Delivery System: // Cartridge // Cassette //.
B. Doors:
1. Quantity: // Single // Double //.
2. Operation: // Automatic // Manual //.
3. Configuration: // Vertical sliding // Side hinged // .
C. Loading: Manual.
D. Heat Source: Electric.
E. Electrical Requirements: // 120V // 208V //.
2.12 LIQUID CHEMICAL STERILIZER:
A. Chamber Volume: 8.7 Gallons.
B. Doors:
1. Quantity: Single.
2. Operation: Manual.
3. Configuration: Top Opening.
C. Standard Cycle:
1. Cycle Time: Up to 25 minutes.
2. Cycle Temperature: 115 - 131 degrees F.
3. Devices Sterilized per Cycle: One.
D. Loading: Manual.
E. Heat Source: Electric.
F. Sterilant Source: Liquid Sterilant S40 Peracetic Acid Sterilant
Concentrate.
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1. Rinse: Filtered tap water exposed to UV rays.
G. Unit Placement: // Counter top // Cart //.
H. Ultraviolet Water and Filter Treatment System:
1. Ultraviolet unit (UV): // Wall // Cart //.
2. Pre-filter Assembly: // Wall // Cart //.
I. Electrical Requirements: As indicated on drawings.
J. Water Source: // Incoming Pressure 40 - 50 PSIG // Incoming Temperature
109 - 140 degrees F //.
2.13 WATER TREATMENT SYSTEM:
SPEC WRITER NOTE: Used to reduce boiler
scaling and instrument spotting during
washer/disinfector and cart washer
cycles.
A. Configuration: Free Standing.
B. Water Treatment Process:
1. Pre-Filtration.
2. Recirculation.
3. Deionization.
4. Final Filtration.
5. Heating.
C. Average Output: 5,000 gallons per day.
D. Electrical Requirements: // 115V // 220V // 230V //.
2.14 DETERGENT DISPENSING SYSTEM:
SPEC WRITER NOTE: Unit selected may
require a water source.
A. Configuration: Wall Mounted.
B. Controls: // PC Based // Microprocessor //.
C. Dispensing Options: // Enzymatic Solution // Detergent // Lubricant
Solution //.
D. Electrical Requirements: // 110V // 120V //.
2.15 STERILIZER-ENCLOSURE PANELS (MODULAR WALLS)
A. Design and custom fabricate to conceal from view body, wiring, piping,
and other appurtenances, and to confine water vapor, gases, and heat in
the enclosed area:
1. Size panels and support members to extend from floor to finished
ceiling.
B. Panels: Fabricate panels of not less than 1.27 mm (0.050-inch) thick
stainless steel, with corners welded. Insulate with 13 mm (1/2-inch)
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moisture-resistant, sound-deadening, material bonded to surface of back
side.
C. Support Columns: Fabricate of not less than 1.52 mm (0.060 inch) thick,
stainless-steel tubing, not less than 38 mm (1-1/2 inches) square, with
mounting plates welded to top and bottom.
1. Location: At each side of doors and at each vertical panel extending
from floor to finished ceiling.
D. Louvers: Stainless steel, located in panels above sterilizer doors, and
with minimum clear opening area equal to 76 sq. mm/mm (3 sq. in./in.)
of sterilizer width.
E. Canopies: Locate above ethylene-oxide sterilizer doors.
1. Securely attach canopies to modular wall panels to produce a tight
fit.
2. Join canopies, front and side panels by welding.
Fabricate of same
material and finish as modular wall panels.
3. Apply moisture- and corrosion-resistant coating on interior
surfaces.
4. Type: Sloping.
5. Overhang: Overhang sterilizer doors a minimum of 305 mm (12 inches).
6. Coordination with Air-Intake: Include air-intake opening in modular
wall panel within canopy, sized to meet airflow requirements
indicated on drawings.
F. Louvered Doors: Fabricated from not less than 9.65 mm (0.38 inch) thick
stainless steel; double pan construction; with internal stiffeners and
sound-deadening insulation.
1. Equip door with heavy-duty hinges and locks.
2. Center louvers and locate them within 152 mm (6 inches) of bottom of
doors.
3. Size louvers to produce clear opening of not less than 25 sq. mm/mm
(1 sq. inch/inch) of sterilizer or aerator width.
4. Equip with spring-hinged, non-louvered, access doors at wall
openings above rack return conveyor.
G. Scribe Strips: Stainless-steel closures to fit assembly to wall or
ceiling.
1. Maximum Width: 102 mm (4 inches).
Use panels to close spaces
greater than 102 mm (4 inches).
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H. Finish: No. 4 finish (bright, directional polish) complying with
NAAMM's "Metal Finishes Manual for Architectural and Metal Products.
"Finish after welding.
PART 3 - EXECUTION
3.1 INSTALLATION
A. Install sterilizers according to manufacturer's written instructions.
B. Coordinate installation with related mechanical and electrical work.
Provide cutouts and openings for plumbing and electrical work as
indicated or as required by trades involved.
3.2 TESTS
A. Field test installed equipment after water and steam systems are
pressurized for proper operation.
1. Operate each unit for six hours through repeated full cycles. During
and after testing, there shall be no evidence of leaks, overheating,
electrical failure, or other symptoms of failure.
2. For units that fail testing, make adjustments and corrections to
installation, or replace equipment, and repeat tests until equipment
complies with requirements.
3.3 PROTECTING AND CLEANING
A. Protect equipment from dirt, water, and chemical or mechanical injury
during the remainder of the construction period.
B. At the completion of work, clean equipment as required to produce
ready-for-use condition.
3.4 INSTRUCTIONS
A. Instruct personnel and transmit operating instructions in accordance
with requirements in specification Section 01 00 00, GENERAL
REQUIREMENTS.
B. Training must be provided by the manufacturer or installer.
- - - E N D - - -
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